The following data is part of a premarket notification filed by Neuwave Medical Inc. with the FDA for Neuwave Microwave Ablation System And Accessories.
| Device ID | K220472 |
| 510k Number | K220472 |
| Device Name: | NEUWAVE Microwave Ablation System And Accessories |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | NeuWave Medical Inc. 3529 Anderson Street Madison, WI 53704 |
| Contact | Mohamed Shariff |
| Correspondent | Mohamed Shariff NeuWave Medical Inc. 3529 Anderson Street Madison, WI 53704 |
| Product Code | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-18 |
| Decision Date | 2022-08-11 |